Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
  • A61L29/08—Materials for coatings
  • A61L29/085—Macromolecular materials

Definitions

• This invention concerns the field of urinary catheters and, in particular, that of packaged urinary catheters.
• Urinary catheters are available on the market in various configurations. They are used both in clinical settings and by patients themselves in daily life and in non-sterile environments. The packaging is subject to various requirements that the urinary catheters that have been available to date only partially satisfy.
• Catheters are placed either for extended periods of time, e.g. in clinical applications in the case of operations, or intermittently, several times a day, for urination, as in the case of patients with paraplegia.
• Catheters normally consist of a tubular part that is thin and flexible, with a rounded end, and, most of the time, have lateral openings in the wall such that the end of the catheter can be inserted into the bladder via the urethra, with the lateral openings allowing urine to pass through the catheter and exit the body.
• a drainage bag or a connector allowing for connection to a drainage bag, usually with a handle at the end of the catheter in order to facilitate the manipulation of the catheter during its insertion into the urethra and its connection to a drainage bag.
• Catheters may be coated with a lubricant to ease their insertion into the urethra.
• catheters There are generally two types of catheters:
• the second category of catheters avoids this issue of activation and splashing, but the catheter generally does not glide as smoothly as catheters with water- activated coatings.
• An object of this invention is thus to provide a ready-to-use urinary catheter kit that is easy to prepare, for a single use, and that is able to glide more smoothly.
• this invention concerns a urinary catheter kit comprising: an aqueous lubricant composition comprising water and at least one polyether- polyurethane P1 thermogelling copolymer, and a urinary catheter with an external coating of thermogelling copolymer P2 comprising at least ether units.
• the urinary catheter is immersed in the aqueous lubricant composition.
• thermogelling copolymer P2 comprises at least some ether units and units selected from urethane units, ester units, and mixtures thereof, preferably urethane units.
• thermogelling copolymer P1 and the thermogelling copolymer P2 have a viscosity of 5 - 100 mPa.s, preferably 10 - 80 mPa.s, at 25°C.
• thermogelling copolymer P1 and the thermogelling copolymer P2 comprise poly(ethylene oxide) and polypropylene oxide) units.
• thermogelling copolymer P1 has a poly(ethylene oxide) content of 50 - 99 wt %, preferably 70 - 95 wt %, more preferably 75 - 90 wt %, based on the total weight of the copolymer.
• the aqueous lubricant composition comprises from 1 to 20% by dry weight, preferably from 2 to 15% by dry weight, more preferably from 3 to 10% by dry weight, of thermogelling copolymer(s) P1, based on the total weight of the aqueous lubricating composition.
• the aqueous lubricant composition further comprises glycerin, preferably in an amount of from 1 to 30% by weight, preferably from 5 to 25% by weight, more preferably from 10 to 20% by weight, based on the total weight of the aqueous lubricating composition.
• the copolymer coating is applied by dipping and drying the catheter in a composition comprising the thermogelling copolymer P2.
• thermogelling copolymer coating P2 is applied by extruding a composition comprising the thermogelling copolymer P2.
• the catheter has two layers, preferably identical, of thermogelling copolymer coating P2.
• thermogelling copolymer comprising at least some ether units, as a coating for a urinary catheter, in a urinary catheter kit in order to reduce the friction coefficient of the catheter.
• the two copolymers P1 and P2 are two thermogelling copolymers.
• the two copolymers P1 and P2 may be identical or different.
• Thermogelling polymer refers to a polymer that is typically liquid at room temperature (app. 22 °C) and that can transition to the gel state when the temperature increases.
• thermogelling copolymers P1 and P2 used in the invention have a viscosity at least 10 times greater at 37 °C than at 25 °C.
• thermogelling copolymers used in the invention will be reached at 37 °C.
• the two copolymers P1 and P2 may have identical or different viscosities.
• thermogelling copolymer P1 and the thermogelling copolymer P2 comprise at least one linear chain comprising ether units.
• thermogelling copolymers (P1 and P2) used in the invention may be as described in document FR2840907.
• the thermogelling copolymers (P1 and P2) are commercially available, e.g. at PolymerExpert.
• the aqueous lubricant composition comprises from 1 to 20% by dry weight, preferably from 2 to 15% by dry weight, more preferably from 3 to 10% by dry weight, of thermogelling copolymer(s) P1, based on the total weight of the aqueous lubricating composition.
• the aqueous lubricant composition further comprises glycerine, preferably in an amount of from 1 to 30% by weight, preferably from 5 to 25% by weight, more preferably from 10 to 20% by weight, based on the total weight of the aqueous lubricating composition.
• thermogelling copolymer P2 The catheter used according to the invention is coated on the outside with a thermogelling copolymer P2.
• the thermogelling copolymer P2 maybe identical or different to the thermogelling copolymer P1.
• each layer may be applied by carrying out a cycle of dipping in a thermogelling copolymer solution, followed by drying, with that cycle being repeated as many times as layers of coating are applied.
• the initial uncoated catheter is made of thermoplastic olefinic (TPO) material.
• the initial uncoated catheter in particular when it is made of TPO, is previously activated, e.g. by plasma, and/or coated with a primer, before being coated with the thermogelling copolymer.
• the primer will typically have a chemical affinity with the material of the uncoated catheter, e.g. TPO, which will facilitate the engraftment of the thermogelling copolymer onto the catheter.
• the primer may comprise a poly(meth)acrylate copolymer.
• the catheter is activated by plasma treatment, then the catheter thus activated is dipped into a primer solution and then dried, preferably air-dried, under laminar flow or in a heated environment.
• the invention also concerns the combined use of a lubricant composition according to the invention and a catheter coating according to the invention in order to improve the smooth gliding of the catheter.
• the friction coefficient is reduced due to the combination of a lubricant composition as defined according to the invention and an outer catheter coating as defined according to the invention.
• the urinary catheter kit according to the invention allows the urinary catheter to attain a friction coefficient of less than 0.1.
• the sample is placed between the jaws and attached to the traction cell.

Landscapes

• Health & Medical Sciences (AREA)
• Epidemiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Materials For Medical Uses (AREA)
• Media Introduction/Drainage Providing Device (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=75850289

Family Applications (1)

Country Status (8)

Family Cites Families (3)

• 2021
  • 2021-02-12 FR FR2101386A patent/FR3119776B1/fr active Active
• 2022
  • 2022-02-10 WO PCT/EP2022/053272 patent/WO2022171749A1/en active Application Filing
  • 2022-02-10 JP JP2023545799A patent/JP2024508626A/ja active Pending
  • 2022-02-10 US US18/263,079 patent/US20240082464A1/en active Pending
  • 2022-02-10 EP EP22704389.0A patent/EP4291260A1/en active Pending
  • 2022-02-10 CA CA3209563A patent/CA3209563A1/en active Pending
  • 2022-02-10 CN CN202280011504.6A patent/CN116867524A/zh active Pending
  • 2022-02-10 BR BR112023014974A patent/BR112023014974A2/pt unknown

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